SPOKANE — It's been nearly a year since the first diagnosed COVID-19 case in Washington state, and there is still not enough testing, health officials say.
The lack of testing is not for lack of capacity at labs but more a supply-and-demand as well as lack of national leadership challenge.
We still do not have a national testing strategy at the federal level, a blight on the Trump administration's response to the pandemic that has left states fighting for the scraps of testing supplies, or getting scooped by the federal government themselves.
The federal testing strategy has been piecemeal and incomplete. For example, at the end of September, the Washington Department of Health announced that they had received their first batch of 149,000 rapid testing kits from the federal government and were sending them to community health centers, critical access hospitals and tribes. The department has not reported receiving more rapid testing kits since then, however.
Long-term care facilities were also supposed to receive their own rapid testing machines from the federal government, but not all facilities in Washington state have received them.
"Federal help isn't taking care of all the skilled nursing facilities, so we will be providing support to those facilities that didn't get those machines," Dr. Charissa Fotinos, who is leading the statewide testing effort, said.
Fotinos is also working on updating the state's testing plan and strategy, which was most recently published this summer.
There are two main types of tests being used by health care providers across the state: PCR tests, which are considered the gold standard when it comes to accuracy, and antigen tests, which are approved for patients experiencing symptoms of COVID-19, and return results in about 15 minutes.
Currently antigen tests are not included in Washington's statewide case count, and the total number of antigen tests account for a small but growing percentage of tests done statewide. In the most recent week data is available, more than 1,500 antigen tests were administered in a single day.
Testing is predominantly led by health care providers and pharmacies statewide, but how and where testing is available varies by region.
Statewide initial testing goals have fallen short. Earlier this year, state health officials said their goal was to get to 40,000 to 50,000 tests per day.
Only at the end of September did statewide testing levels begin to crest 20,000 tests per day. The most tests conducted in a day thus far in the pandemic was on Nov. 2, when 27,796 tests were administered on one day.
And while testing has only slightly improved in recent months, positivity rates have skyrocketed, meaning disease activity is really on the rise and not a result of more testing. Fotinos said the state is still not where it should be for testing.
"I would be remiss if I told you we're testing enough," she said. "We're seeing more cases; we know there's more infection out there if the level is the same. I'd say we're holding, our numbers of tests aren't rising with that, so we need to encourage people to get tested more or figure out how they can get tested."
Supply and demand
The state has capacity in its labs to run specimens for 50,000 tests per day, Fotinos said, excluding large commercial labs like Quest or LabCorps, so capacity is not the issue.
So with all that capacity, why aren't more tests being done?
Fotinos said it's not a matter of lab capacity, but much more one of supply and demand.
"Labs are still struggling with supplies," Fotinos explained.
There is a lot of demand for the plastics and reagents needed to process and keep samples preserved until they are processed. With no federal testing strategy or plan, states and local health jurisdictions are competing with the federal government to buy these resources, Fotinos said.
"There's still competition for a relatively limited resource," she said. "There are more constraints on the processing side."
Spokane Regional Health District's interim health officer, who worked at lab companies most recently in his professional career, agrees.
Dr. Francisco Velázquez, who worked for Quest Diagnostics and Pathology Associates Medical Laboratories, which LabCorps acquired, said that the diagnostics industry was not prepared for the level of demand in such a short period of time.
"It usually takes 12 to 18 months to get to a point where testing is widely available, so we did that in months," he said, acknowledging that the companies bolstered a tremendous effort initially.
Demand for testing has gone up locally in Spokane County in recent weeks, leading CHAS, the group of federally qualified health clinics administering free testing and testing for residents with no health insurance, to alter its protocols.
Initially, CHAS opened up its rapid testing to school district employees and students for a week or so, but after being overwhelmed by the demand for it, they had to change course.
The majority of testing offered by CHAS is PCR tests, where patients swab the front part of their nose, and those samples are sent to Incyte Diagnostics to be processed.
Rapid tests are only being used at one CHAS urgent care site now, only if a provider determines it's high-need and the person has symptoms. There are two types of rapid tests used by CHAS. If rapid tests come back positive, they are considered accurate, but if they come back negative, a provider might suggest a PCR test as well.
Velázquez believes that a national strategy would trickle down and impact local public health efforts. He hopes that testing becomes more advanced moving forward.
"We've used testing thus far basically for cause, either because you come in with symptoms that are suspicious or you've been exposed to someone. We're not at the level where we're testing asymptomatic individuals in the community just because," he said.
Some colleges have used broader surveillance testing, sampling sewage water, for example, to monitor outbreaks and COVID activity on campuses. Velázquez said before his appointment, he was working with Dr. Bob Lutz and some researchers at Washington State University to see if they can develop a model to develop surveillance testing for some industries.
Still in need of a federal plan
Just because there is a promising vaccine on the way does not eliminate the need for a comprehensive testing strategy, experts say.
In the absence of a federal plan, many think tanks and institutes have produced their own testing plans throughout the pandemic. Mara Aspinall, a professor at Arizona State University, helped write a proposed testing plan from the Rockefeller Institute this summer but said it is still relevant today.
"We need a testing strategy, I think, more like for the next year and probably continuing beyond that," Aspinall said.
The Rockefeller plan calls for $75 billion in federal investment to dramatically increase testing and make it free and accessible for all Americans. The Rockefeller report also calls for a dramatic increase in tests conducted per week in the U.S.
The report calls for an ideal 30 million tests conducted each week. Currently, the U.S. tested 3.1 million specimens in the most recent week, according to Centers for Disease Control and Prevention data.
The virus, as is evidenced simply by the I-90 corridor, knows no state borders, therefore dampening the effectiveness of strategies, if one state is implementing them while another is not.
"Without a national policy, it's like peeing in one side of the pool and expecting it to not get to the other side," she said.
Aspinall believes that "Operation Warp Speed" and the aggressive approach of the federal government to get multiple viable vaccines to the market could have been implemented for other parts of the pandemic response.
"I think in hindsight, we should have had the equivalent of (Operation Warp Speed) for testing," she said.
President-elect Joe Biden does have the beginnings of a national testing plan listed on his transition website and has already organized a COVID-19 advisory task force.
He plans to double the number of drive-through testing sites nationwide and invest in more instant and at-home tests to scale up nationwide testing.
Biden's plan also calls for standing up a Pandemic Testing Board, like Roosevelt's War Production Board, in order to distribute millions of tests. He also plans to establish a job corps to get 100,000 people to support contact tracing and COVID-19 response for at-risk populations.
Waiting for a vaccine
Distributing a vaccine so that every American can have access to it is no easy feat. The coordinated planning efforts of states, in accordance with the CDC, are well underway but not entirely seamless.
While no equitable framework has been handed down at the federal level, Washington DOH has laid out phases of who would receive the vaccine first, as it will almost certainly come in small waves of doses as it's distributed.
Phase One includes high-risk health care workers, which amounts to an estimated 500,000 residents, first responders, older adults in long-term care facilities and people with co-morbidities in the state. All together this group of Washington residents accounts for more than an estimated 3.5 million Washington residents.
After those groups receive vaccines, subsequent phases call for vaccines for educators, child care and essential workers, people experiencing homelessness and all older adults. Later, young adults, children and other essential workers and everyone else who does not fit into above categories could get a vaccine.
If this framework ends up driving distribution, it could take some significant time to get vaccines to everyone. Statewide efforts with pharmacies and hospitals to distribute the vaccine are in the works.
"It is very likely it will take months to get a vaccine to everyone, maybe all of 2021," Dr. John Lynch, a University of Washington professor and medical director at Harborview Medical Center, said at an October webinar.
States were asked to be ready to receive vaccines as early as Nov. 15, but as of Sunday the Food and Drug Administration has not granted emergency use authorization to a vaccine candidate.
Because there are several vaccine candidates, state health officials are working with health care partners to ensure that ultra-cold and frozen storage is available for vaccines. There is also the added complication that most vaccine candidates are two-dose vaccines, meaning even more necessary storage space and the obvious need for follow-up with patients.
Michele Roberts, acting assistant secretary of health, told reporters earlier this month that the department is only expecting the state will receive a few hundred thousand doses in the first couple months, barely or not even enough to give vaccines to all health care workers.
"It will take some time to even vaccinate that priority group," Roberts said.
The department plans to identify about five initial sites, most likely hospitals, for the CDC to send vaccines first, but as of Friday, a list of those sites was still not available. Roberts said finding the places to send vaccines initially is not the hardest part, however.
"The second part is harder: how are we going to choose who gets the first vaccines?" she said.
2021 will bring more mask-wearing and social distancing.
While there is a definite possibility that there will be a COVID-19 vaccine distributed before the end of 2020, health officials and experts warn that the wait will be long for a vaccine to be distributed to all Americans.
Lynch warned in a mid-October webinar that the end is not really in sight, or at least not in the next few several months.
"My goal isn't to alarm people, but it's actually to kind of coax people into recognizing we have to settle into this, we've got to hunker down and accept it," Lynch told the Spokesman-Review in October.
Vaccine development is progressing at impressive speeds, and yet Election Day came and went with no vaccine ready to distribute.
Pfizer's vaccine candidate is expected to be submitted to the FDA for approval this month, but even when it is, only 50 million doses will be ready by the end of 2020 for the entire globe.
This would trickle down to Washington state in the form of maybe tens of thousands of doses, not enough to even vaccinate all the front-line health care workers by the Department of Health's count.
If the CDC have a limited supply of vaccines this year, Washington is expected to get about 2% of what they need, or between 150,000 to 450,000 doses in the first two months, according to the Washington vaccine plan.
Health officials expect and are preparing for multiple vaccines to come on the market by next year, but the logistics of getting vaccines from the federal government to providers in communities throughout the state will require an inevitable amount of logistics.
In the meantime, some of the country's top health officials have taken a more optimistic approach this month, with Dr. Anthony Fauci saying vaccines could be available to all Americans by April.
Regardless, the pandemic will be with us for at least six more months.
"The important part is it's going to take a long time," Lynch said in October. "It might take a year or more to get all this stuff done, so don't think this will happen in the short-term."